Preliminary studies on the relationship among peel force, quantitative measures of skin damage and subjective discomfort.
OBJECTIVE
The ability to anticipate skin damage and subject/patient discomfort due to the removal of adhesive materials without human testing is currently limited. While standardized laboratory methods have been developed, their ability to model and predict the interaction with relevant living substrate is imperfect. The aim of this study was to assess the adhesion of various materials as a function of time using the abdomen as the body site, and determine if a relationship existed with skin damage and subject discomfort.


METHODS
Strips of six different materials used in medical devices and known to have different adhesive properties in the laboratory setting were tested in this study. The strips were adhered to the abdomens of normal volunteer subjects for varying periods of time. Peel force was measured under conditions developed to lessen the influence of skin elasticity. Disturbance of the skin barrier was assessed by measuring transepidermal water loss; erythema by reflectance L*a*b* measurements; skin cells removal by quantitation of dyed cells adhering to the test strips; and discomfort using subject self-assessment.


RESULTS
When measured at times from 30 min to 72 h after application, the peel force was highest for materials at 30 min. The peel force for one of the six materials, designated F, was clearly higher than the others at time points from 30 min to 48 h after application. Interestingly, this material caused less disruption to the skin barrier and was reported to cause less discomfort.


CONCLUSIONS
In this system, there was not a correspondence between adhesion as measured by peel force and skin damage or self-report of discomfort. Further investigations will be required to establish the predictive value of other biophysical measurements and discomfort.
Murahata
Richard I
RI
Hollister Incorporated, Libertyville, IL 60048, USA. richard.murahata@hollister.com
Taylor
Michael G
MG
Damia
Jonn
J
Grove
Gary L
GL
D001458:Bandages / Q000009:adverse effects*; D020878:Device Removal; D004867:Equipment Design; D019544:Equipment Failure Analysis / Q000379:methods*; D006801:Humans; D010146:Pain / Q000175:diagnosis* / Q000209:etiology*; D010865:Pilot Projects; D012867:Skin / Q000293:injuries* / Q000473:pathology*; D013314:Stress, Mechanical; D014014:Tissue Adhesives / Q000009:adverse effects / Q000737:chemistry
D014014:Tissue Adhesives